Primary care randomised controlled trialof a tailored interactive website for the self-management of respiratory infections Internet Doctor Paul Little,1Beth Stuart,1Panayiota Andreou,1L
Trang 1Primary care randomised controlled trial
of a tailored interactive website for the self-management of respiratory
infections (Internet Doctor)
Paul Little,1Beth Stuart,1Panayiota Andreou,1Lisa McDermott,1Judith Joseph,2 Mark Mullee,3Mike Moore,1Sue Broomfield,1Tammy Thomas,1Lucy Yardley2
To cite: Little P, Stuart B,
Andreou P, et al Primary
care randomised controlled
trial of a tailored interactive
website for the
self-management of respiratory
infections (Internet Doctor).
BMJ Open 2016;6:e009769.
doi:10.1136/bmjopen-2015-009769
▸ Prepublication history for
this paper is available online.
To view these files please
visit the journal online
(http://dx.doi.org/10.1136/
bmjopen-2015-009769).
Received 5 November 2015
Revised 4 December 2015
Accepted 16 December 2015
1 Primary Care Group,
Primary Care and Population
Sciences Unit, University of
Southampton, Southampton,
UK
2 Centre for the Applications
of Health Psychology,
University of Southampton,
Southampton, UK
3 Research Design Service
South Central, Primary Care
and Population Sciences
Unit, University of
Southampton, Southampton,
UK
Correspondence to
Dr Paul Little;
P.Little@soton.ac.uk
ABSTRACT
Objective:To assess an internet-delivered intervention providing advice to manage respiratory tract infections (RTIs).
Design:Open pragmatic parallel group randomised controlled trial.
Setting:Primary care in UK.
Participants:Adults (aged ≥18) registered with general practitioners, recruited by postal invitation.
Intervention:Patients were randomised with computer-generated random numbers to access the intervention website (intervention) or not (control) The intervention tailored advice about the diagnosis, natural history, symptom management ( particularly
paracetamol/ibuprofen use) and when to seek further help.
Outcomes:Primary: National Health Service (NHS) contacts for those reporting RTIs from monthly online questionnaires for 20 weeks Secondary:
hospitalisations; symptom duration/severity.
Results:3044 participants were recruited 852 in the intervention group and 920 in the control group reported 1 or more RTIs, among whom there was a modest increase in NHS direct contacts in the intervention group (intervention 37/1574 (2.4%) versus control 20/1661 (1.2%); multivariate risk ratio (RR) 2.25 (95% CI 1.00 to 5.07, p=0.048)) Conversely, reduced contact with doctors occurred (239/1574 (15.2%) vs 304/1664 (18.3%); RR 0.71, 0.52 to 0.98, p=0.037) Reduction in contacts occurred despite slightly longer illness duration (11.3 days vs 10.7 days, respectively; multivariate estimate 0.60 days longer ( −0.15 to 1.36, p=0.118) and more days of illness rated moderately bad or worse illness (0.52 days; 0.06
to 0.97, p=0.026) The estimate of slower symptom resolution in the intervention group was attenuated when controlling for whether individuals had used web pages which advocated ibuprofen use (length of illness 0.22 days, −0.51 to 0.95, p=0.551; moderately bad or worse symptoms 0.36 days, −0.08 to 0.80, p=0.105).
There was no evidence of increased hospitalisations (risk ratio 0.25; 0.05 to 1.12; p=0.069).
Conclusions:An internet-delivered intervention for the self-management of RTIs modifies help-seeking behaviour, and does not result in more hospital
admissions due to delayed help seeking Advising the use of ibuprofen may not be helpful.
Trial registration number:ISRCTN91518452.
BACKGROUND
Most people suffer a respiratory tract infec-tion (RTI) every year, many suffering more than once, with 20–30% of the population
Strengths and limitations of this study
▪ This is, to the best of our knowledge, the only substantial trial to date to address the effective-ness of support for the management of respira-tory infections using the internet.
▪ The rate of uptake following invitation was low, but is what would be expected for a free-standing internet-delivered intervention and 70% follow-up was achieved, which is high for a free-standing internet intervention —and there was little evidence of attrition bias.
▪ The primary outcome had to be changed to monthly questionnaires since the intervention development had to take account of the context
of the provision of National Health Service (NHS) Direct, and the monthly self-report data was the only source of data about NHS Direct contacts (in addition to documenting episodes that clini-cians did not include in the records), but recall
of contacts made during an infection experienced
in the previous month are likely to suffer minimal recall bias.
▪ Participants were less deprived than non-participants, but controlling for deprivation made little difference to the estimates and there was no significant interaction of the intervention with deprivation.
▪ The number of participants who experienced one
or more respiratory tract infections was lower than expected, which will have reduced the power to detect differences.
Trang 2consulting primary care at least once each year, which
represents a significant call on healthcare resources.1 2
However, in most cases, RTIs do not present a serious
threat to the patient’s health and with access to the right
information many illnesses could be self-managed at
home This is particularly important as, unfortunately,
when a doctor is consulted, antibiotics are normally
given.1 Provision of such information prior to
consulta-tions could potentially result in patients having improved
symptom control, lower attendance at general
practi-tioner (GP) surgeries and reduced antibiotic
prescrip-tions—which could be one important tool in the fight
against antibiotic resistance.3 A systematic review has
documented several trials that have used information
to modify consultations for RTIs among children.4
However, there were only three older trials (the last
pub-lished in 1991) that addressed the issue of providing
spe-cific information prior to consultation for RTIs.4Studies
in adults also demonstrate that providing information
booklets may help modify consultation behaviour,5–7but
a wide range of symptoms and conditions were assessed
in the latter studies, so the precise role in interventions
for modifying consultations for RTIs is less clear
Booklets are no longer likely to be distributed as a
source of advice regarding the self-management of
respiratory infection given the widespread and growing
access to the internet as a source of information prior to
consulting—with more than 80% of families currently
having access to the internet (rising by 5% each year)
Web-based interventions can enable patients to access
reliable self-care information from their home, make an
informed decision on how best to manage their
symp-toms and decide whether they need to visit their doctor
Recently, a trial has reported that advice to use
ibufen resulted in both poor symptom control (more
pro-longed illness) and increased complication—presumably
by interfering with the inflammatory and immune
response.8 A potential problem about providing
self-management advice is that patients might be
encour-aged to self-manage serious infections inappropriately
(ie, when they really need to see the doctor), and so
develop complications unnecessarily This is a major
concern for doctors and patients9–11—highlighting the
importance of good safety-netting advice (ie, advice
about when to consult further) and the need to
docu-ment the impact of interventions on hospital admissions
However, it is also plausible that good self-management
advice about appropriate early assessment of more
severe illness could reduce hospital admissions
We have developed a theoretically informed
internet-delivered intervention to manage RTIs among adults
(‘The Internet Doctor’) that we have shown in a small
exploratory trial results in higher levels of satisfaction,
enablement and understanding of illness.12 We report a
larger trial of this website to address whether
consulta-tion behaviour can be modified, and to document
potential harms (including hospital admissions) over a
1-year period
METHODS
We used procedures very similar to our previous leaflet trial.6A random selection of adults in the computerised practice registers from 35 practices in southern England were identified by the practice staff and letters sent to patients inviting them to participate Patients willing to participate were asked to log on to the website to confirm consent Patients were also given contact details to enable them to email or talk to the research team before agree-ing to participate, or if they had problems loggagree-ing in Only one participant per household could participate
Changes to the protocol
We originally specified a 12-month period for measuring the primary outcome, but in developing the interven-tion, we needed to incorporate not just advice to see the
GP but also advice to use National Health Service (NHS) Direct, and therefore, to document NHS Direct contacts We had not anticipated this and so required self-report of the monthly data as our primary outcome
To provide monthly follow-ups for a year would then have had two effects—engagement of participants would have been much more difficult and much more resource intensive than originally anticipated The most meaning-ful and feasible assessment of the primary outcome was, therefore, the monthly reports of consulting their GP for those individuals who reported a respiratory infec-tion (the interveninfec-tion was not designed to help those who did not suffer an infection)
Inclusion criteria Adult patients (aged 18+ years) from GPs computerised lists
Exclusion criteria Patients with severe mental problems (eg, major uncontrolled depression/schizophrenia; de-mentia; severe mental impairment—unable to complete outcomes) or terminally ill
Randomisation Once logged in, patients were rando-mised automatically by the website using computer gen-erated random numbers to one of the following groups:
▸ Access to an interactive website providing tailored advice; this was reinforced by email prompts and reminders to use the website; patients were given information about the natural history, self-care advice, and advice about the use of over-the-counter medica-tion Outcome measures were documented online by participants following email prompts each month
▸ Normal care (as the control group, outcome mea-sures were collected online, but access to the tailored advice website was at the end of the trial)
Randomisation was not stratified, with no blocking, and participants were blind to their randomisation group at the point of consent (but clearly could not be blinded once they knew their randomisation group)
Study groups Intervention group
Participants had access to the internet-delivered inter-vention for 20 weeks On logging onto the website, users could select tailored advice on (1) whether and why
Trang 3they need/do not need to consult the GP and (2) how
to self-care for RTIs Patients selecting consultation
advice completed questions about their symptoms and
medical history, and were then presented with tailored
advice recommending either self-management (for mild
symptoms), for more severe symptoms (eg, haemoptysis,
prolonged fever) phoning the ‘NHS Direct’ helpline,
which provided nurse-led advice about the need to seek
further medical help, or alternatively, seeking medical
attention immediately (for symptoms potentially posing
serious risks, eg, reduced consciousness level, chest
pain) Patients were given the opportunity to challenge
this advice by selecting further in-depth information
about the symptoms of common complications or
serious illness compatible with their symptoms, and by
clicking on frequently asked questions (eg, regarding
the need for antibiotics and typical time-course of
symp-toms) The self-care section provided options to select
advice on self-management without medication
(includ-ing rest,fluid intake) or with medication For those who
wanted to take medication, over-the-counter remedies
were recommended as an effective and preferable
alter-native to seeking antibiotics from the GP, and in
particu-lar, optimising the use of paracetamol and encouraging
the use of ibuprofen The website was theory-based,
addressing all components of the common-sense model
of self-regulation of illness13 (ie, perceived symptoms,
cause, timeline, physical and emotional consequences and the possibility for control/cure), and used the prin-ciples of social cognitive theory14 to address expected outcomes of consultation and care, and build self-confidence for self-care Extensive qualitative piloting15
established that the website was accessible to people with very limited education and no previous computer experience, and quantitative piloting in several hundred people indicated that it increased confidence when self-managing a RTI, and had the potential to reduce consultations.12
Control group (normal care)
As in the intervention group, the control group had access to the GP/practice in the normal way for respira-tory illnesses and influenza-like-illness (ILI) The control group was offered access to the website at the end of the study to minimise resentful demoralisation.16
Primary outcome
GP consultations
We hypothesised that the intervention would reduce the number of contacts with GPs for individuals who suf-fered a RTI Patients were prompted by email to log onto the website monthly, every 4 weeks, until 20 weeks (ie, weeks 4, 8, 16, 20) to complete questionnaires about illnesses during the last month—since the duration of
Figure 1 CONSORT diagram.
Trang 4symptoms can be remembered reliably over a period of
a few weeks.17 18
We also performed an assessment of the consultations
that were recorded in primary care by a blinded
assess-ment of the primary care records Although this does
not capture all contacts with health professionals (and
also does not capture contacts with NHS Direct) it has
been shown to be reliable.19
Secondary outcomes
The use of antibiotics was documented as prescription
of antibiotics, from patient records
For each episode, the index person also documented:
whether they contacted NHS Direct for phone-based
advice; the nature of the infection; the duration of
symp-toms rated moderately bad (which we have shown in
pre-vious research is a useful outcome and sensitive to change
for individuals,18 and can be remembered reliably over a
period of a few weeks17 18); the number of days where
work/normal activities were impaired;18and smoking status
Patients were also asked to complete measures of their symptoms and concern about them at the time of illness, levels of health anxiety, consulting preferences, and attitudes to the intervention; a full analysis of these potential mediators and moderators of outcomes will be presented in a process analysis in a future paper
Sociodemographic and comorbidity data
We collected age, gender and educational level from the participant online and prior comorbidities and consulta-tions from the notes review
Sample size calculation
We estimated that a trial among a minimum of 2266 patients would allow us to detect a 25% reduction in attendance with RTIs (20% vs 15% requires 906 per group, with completed outcomes or 2266 allowing for 20% loss to follow-up; for α=0.05 and β=0.2), and a 0.2 standardised effect size for continuous outcomes
Analysis
We performed an intention-to-treat analysis, and the syntax was written blind as to group No interim analysis was performed The proportions attending with RTI in Table 1 Baseline characteristics*
(54.4%)
816/1490 (54.8%)
(49.1%)
688/1483 (46.4%)
(36.0%)
549/1481 (37.1%) Number of times consulted
a doctor about RTI in the
previous year
0.50 (1.2) 0.54 (1.2)
Household composition (%)
(12.4)
191/1489 (12.8)
(67.3)
1015/1489 (68.2)
(10.3)
145/1489 (9.7) Children aged under
16 years
144/1432 (10.1)
138/1489 (9.3) Highest qualifications
No formal educational
qualifications
108/1432 (7.5)
121/1490 (8.1) Cses/o ’levels/gcses (or
similar)
265/1432 (18.5)
279/1490 (18.7)
A ’levels (or similar) 151/1432
(10.5)
157/1490 (10.5) Diploma/other vocation
qualification
317/1432 (22.1)
322/1490 (21.6)
(15.2)
244/1490 (16.4) Postgraduate or
professional qualification
373/1432 (26.1)
367/1490 (24.6)
*Data are means (SD) or numbers (%).
IMD, index of multiple deprivation; RTI, respiratory tract infection.
Table 2 Baseline characteristics of participants who reported at least one respiratory tract infection (RTI)*
Ever smoked 448/918 (48.8%) 393/850 (46.2%) Comorbid condition 329/912 (36.1%) 324/850 (38.1%) Number of times
consulted a doctor about RTI in the previous year
0.54 (1.17) 0.54 (1.19)
Household composition (%)
Spouse/partner 612/920 (66.5) 589/851 (69.2) Other adult(s) 96/920 (10.4) 87/851 (10.2) Children aged
under 16 years
102/920 (11.1) 77/851 (9.1) Highest qualifications
No formal educational qualifications
66/920 (7.2) 62/852 (7.3)
Cses/o ’levels/
gcses (or similar)
166/920 (18.0) 143/852 (16.8)
A ’levels (or similar)
102/920 (11.1) 88/852 (10.3) Diploma/other
vocation qualification
203/920 (22.1) 196/852 (23.0)
Postgraduate or professional qualification
244/920 (26.5) 215/852 (25.2)
*Data are means (SD) or numbers (%).
Trang 5the intervention and normal care groups were evaluated
using logistic regression to calculate ORs (which were
converted to risk ratios using the formula of Zhang20),
with CIs Outcomes measured on a continuous scale
(duration and severity of symptoms) were analysed using
multiple linear regression All continuous outcome
vari-ables were checked for the assumption of normality of
residuals The models controlled for variables likely to
predict consultation: gender, age, highest educational
qualification, smoking status, whether there were
chil-dren aged under 16 years living in the household, any
comorbid condition, the number of times the patient
reported consulting a doctor about an RTI in the
12 months prior to the study, and index of multiple
deprivation (IMD uses post codes to estimate
depriva-tion across a number of domains; https://www.gov.uk/
government/statistics/english-indices-of-deprivation-2010)
Given previous findings of increased symptom burden
when health professionals give advice to use ibuprofen,8
and the findings of increased symptom burden in the
intervention group of the current study, a post hoc
sec-ondary analysis explored the impact of controlling for
whether pages advocating the use of ibuprofen had
been viewed
RESULTS
Totally, 43 769 patients were invited, of whom 3044
parti-cipants consented (from 17 January 2012 to 20 October
2013), and 3355 gave reasons for declining (commonly
not enough time, or insufficient access to the internet,
or uncomfortable using computers, but also a variety of
other reasons; see figure 1) Table 1 demonstrates that
the groups were well balanced for a range of variables
(and table 2 shows this for those who reported at least
one respiratory infection during follow-up) Although groups in the study were well balanced for deprivation, those who agreed to take part were less deprived than non-participants (IMD score 16.1 (SD 11.1), hence results controlled for IMD score
Table 3 documents a modest increase in contacts for NHS Direct among those who had an RTI in the inter-vention group (37/1574 (2.4%) versus 20/1661 (1.2%), multivariate risk ratio (RR) 2.25 (1.00 to 5.07, p=0.048), but reduced contact with doctors (239/1574 (15.2%) vs 304/1664 (18.3%), risk ratio 0.71, 95% CI 0.52 to 0.98, p=0.037)
Possible harms
The reduction in contacts with doctors occurred despite slightly longer duration of illness (>11.3 vs 10.7 days); multivariate estimate 0.60 days longer (−0.15 to 1.36, p=0.118) and more days experienced of moderately bad
or worse illness 4.59 vs 4.00 days (multivariate estimate 0.52 days; 0.06 to 0.97, p=0.026) The latter estimates of increased symptom burden were reduced when control-ling for whether individuals used ibuprofen from the pages on the website (length of illness 0.22, −0.51 to 0.95, p=0.551; moderately bad or worse symptoms 0.36,
−0.08 to 0.80, p=0.105) There was no evidence that self-management advice resulted in delayed consultations for serious illnesses (eg, lobar pneumonia; meningitis; septicaemia), and hence, increased hospitalisations: in fact there were reduced hospitalisations, albeit not statis-tically significant, both in the shorter term (20 weeks) and longer term (1 year) (tables 4–7)
Analysis of the follow-up data from the notes review for the whole sample is shown in tables 6 and 7; as expected, since most such individuals did not have a
Table 3 Monthly reports of health service use and duration of illness (weeks 4, 8, 12, 16 and 20) for participants who
reported at least one respiratory infection during the 20 weeks
Univariate risk ratio (95% CI; p value)
Multivariate risk ratio* (95% CI; p=value) Reported episodes of respiratory tract
infection
1665/5697 (29.23%)
1578/5291 (29.82%)
1.03 (0.93 to 1.12;
p=0.566)
1.04 (0.94 to 1.14; p=0.461)
Of those who reported a respiratory tract infection
Saw a doctor about illness (as a
proportion
of the number of episodes)
304/1664 (18.27%)
239/1574 (15.18%)
0.75 (0.56 to 1.01;
p=0.061)
0.71 (0.52 to 0.98; p=0.037)
Contacted NHS Direct about illness 20/1661
(1.20%)
37/1574 (2.35%) 2.34 (1.07 to 5.10;
p=0.034)
2.25 (1.00 to 5.07; p=0.048)
Difference (95% CI;
p value) Length of illness (days) 10.68 (9.45) 11.30 (9.89) 0.58 ( −0.15 to 1.30;
p=0.119)
0.60 ( −0.15 to 1.36; p=0.118)
Days moderately bad or
worse NHS,
National Health Service
4.00 (5.48) 4.59 (6.88) 0.47 (0.03 to 0.92;
p=0.035)
0.52 (0.06 to 0.97; p=0.026)
*Multivariate model controls for gender, age, highest educational qualification, smoking status, whether there are children aged under
16 years living in the household, any comorbid condition, index of multiple deprivation score, and the number of times the patient reported consulting a doctor about an RTI in the 12 months prior to the study.
Trang 6respiratory infection, there was no clear evidence of a
reduction in consultations The characteristic of those
followed-up and not followed-up, were also similar
(table 8)
DISCUSSION
This is, to our knowledge, the only substantial trial to
date to address the effectiveness of support for the
man-agement of respiratory infections using the internet
Although relatively limited follow-up was possible
(20 weeks) there was reduced contact with GPs, and
pos-sibly a longer term reduction in hospital admissions
There was a slight increase in contact with NHS Direct,
consistent with the advice given by the intervention for
management of more severe symptoms that did not
warrant immediate medical attention
Limitations
A total of 70% follow-up was achieved, which is high for
a free-standing internet intervention, and there was little
evidence of attrition bias There was no differential
attri-tion bias which suggested that resentful demoralisaattri-tion
was minimised by offering the delayed intervention21 22
The primary outcome was initially anticipated to be at
12 months, but a shorter time period was necessary due
to the need to engage participants and achieve good
follow-up rates with the monthly questionnaires
Monthly questionnaires were also needed, since the
intervention during development had to take account of
the context of the provision of NHS Direct, and the
monthly self-report data was the only source of data about NHS Direct contacts (in addition to documenting episodes that clinicians did not include in the records) The monthly data has the limitations of self-report, and could be biased if GP consultations were discouraged by the Internet Dr, but in fact, the Internet Dr did not gave advice about when to see the doctor promptly If self-reports of RTIs were biased, we would also have expected different numbers of RTIs to be reported in the intervention group which did not occur Bias in self-report would also not explain the opposite directions of consultation with NHS Direct and with GPs, and which also makes type I errors unlikely The estimate derived from primary care notes review for consultations (risk ratio 0.87, lower bound of the 95% CI 0.51) was also consistent with the estimate from the monthly data (risk ratio 0.71) The rate of uptake following invitation was low, but is what would be expected for a free-standing internet-delivered intervention, particularly as this is mostly for minor and common conditions that most will feel, rightly or wrongly, reasonably confident to manage However, the patients who did participate were those that the intervention is likely to help, that is, participants who are sufficiently concerned about their symptoms to
be motivated to use a self-management website There is also a circularity in engaging participants—physicians are much more likely to refer to a free-standing interven-tion once it has been shown to be effective, so the first priority is to demonstrate effectiveness Participants were less deprived than non-participants, but controlling for
Table 4 Health service use recorded in primary care records in the 20 weeks following the date of consent for participants who reported at least one episode of respiratory tract infection (RTI)
Control (%) Intervention (%)
Univariate risk ratio (95% CI; p=value)
Multivariate risk ratio* (95% CI; p=value) Any consultations 98/912 (10.8) 88/851 (10.3) 0.96 (0.73 to 1.26; p=0.782) 0.89 (0.65 to 1.23; p=0.514) Any antibiotic prescriptions 66/880 (7.5) 64/827 (7.7) 1.03 (0.74 to 1.43; p=0.853) 0.94 (0.64 to 1.38; p=0.759) Any hospitalisations 7/823 (0.9) 1/765 (0.1) 0.15 (0.02 to 1.24; p=0.079) 0.13 (0.02 to 1.11; p=0.062) Any referrals 10/824 (1.2) 8/771 (1.0) 0.86 (0.34 to 2.14; p=0.740) 0.77 (0.26 to 2.24; p=0.625)
*Multivariate model controls for gender, age, highest educational qualification, smoking status, whether there are children aged under 16 years living in the household, any comorbid condition, index of multiple deprivation score, and the number of times the patient reported consulting a doctor about an RTI in the 12 months prior to the study.
Table 5 Health service use recorded in primary care records in the 12 months following the date of consent for patients who experience at least one episode of respiratory tract infection (RTI) in the first 20 weeks
Univariate risk ratio (95% CI; p=value)
Multivariate risk ratio (95% CI; p=value) Any reconsultations 176/912 (19.3%) 164/851 (19.3%) 0.99 (0.82 to 1.16; p=0.989) 0.93 (0.73 to 1.16; p=0.509) Number of reconsultations † 0.36 (1.01) 0.33 (0.85) 0.91 (0.71, 1.17; p=0.475) 0.94 (0.72, 1.21; p=0.619) Any antibiotic prescriptions 115/851 (13.5%) 107/794 (13.5%) 0.99 (0.78 to 1.30; p=0.982) 1.00 (0.74 to 1.33; p=0.997) Any hospitalisations 8/748 (1.1%) 1/689 (0.2%) 0.14 (0.02 to 1.08; p=0.059) 0.13 (0.02 to 1.05; p=0.056) Any referrals 14/750 (1.9%) 12/699 (1.7%) 0.92 (0.43 to 1.96; p=0.830) 0.87 (0.35 to 2.16; p=0.799)
*Multivariate model controls for gender, age, highest educational qualification, smoking status, whether there are children aged under 16 years living in the household, any comorbid condition, index of multiple deprivation score, and the number of times the patient reported consulting a doctor about an RTI in the 12 months prior to the study.
†Reported as the mean (SD) The median is 0 and the IQR is (0, 0) The range is 0–8.
Trang 7deprivation made little difference to the estimates, and
there was no significant interaction of the intervention
with deprivation The number of participants who
experienced one or more RTIs was lower than expected,
which will have reduced the power to detect differences
Patients’ self-reported contacts with the NHS, but
recall of contacts made during an infection
ex-perienced in the previous month are likely to suffer
minimal recall bias Self-report is the only method of
capturing contacts with NHS Direct and, furthermore,
the estimates of consultations and admissions purely
based on primary care notes suggested changes in the
same direction and of a magnitude similar to the
monthly self-reports
Main findings
The estimated reduction in consultations with GPs with
the website was similar to the effectiveness of the
pamphlet we developed for predominantly respiratory
illness.6This suggests the internet-delivered intervention
is potentially more effective than a pamphlet, given the
current widespread availability of NHS Direct online
resources and other internet-delivered advice regarding
infections The estimated 25% reduction in GP
consulta-tions, even if only over a period of a few months, would
provide very considerable relief in terms of pressure on
services during the winter months Perhaps more sur-prising is that there was a reduction in hospital admis-sions, albeit non-significant, suggesting the intervention
is unlikely to results in delayed presentation of serious illness—and if anything could help in relieving pressure
on hospital services One explanation for reduced admission might be that those with severe symptoms were discouraged from seeing the doctor, but since Internet Dr encouraged individuals to seek medical help promptly with severe symptoms this seems unlikely Although the study was not powered to assess a reduction
in antibiotic use, nevertheless the estimates of a 6–12% reduction in antibiotic prescriptions over 6–12 months is consistent with the observation that most individuals who attend the GP get antibiotics,1 so reducing atten-dance would be expected to potentially provide an impor-tant component in the population-level fight against antibiotic resistance, given the evidence that primary-care prescriptions are a key component in driving antibiotic resistance.3
Harms
In terms of major harms, the upper bound of the CI suggests we can be reasonably sure that no increase in hospital admissions occurred The most surprising finding was that in the intervention group both
Table 6 Health service use in the 20 weeks following the date of consent based on review of primary care notes
Univariate risk ratio (95% CI; p=value)
Multivariate risk ratio (95% CI; p=value) Any reconsultations 126/1418 (8.89%) 118/1483 (7.96%) 0.90 (0.71 to 1.14; p=0.368) 0.95 (0.79 to 1.15; p=0.612) Number of
reconsultations †
0.18 (0.75) 0.16 (0.66) 0.88 (0.64 to 1.21; p=0.434) 0.97 (0.69 to 1.35; p=0.854) Any antibiotic
prescriptions
86/1378 (6.24%) 83/1448 (5.73%) 0.92 (0.68 to 1.23; p=0.569) 0.88 (0.63 to 1.24; p=0.473) Any hospitalisations 8/1301 (0.61%) 2/1368 (0.15%) 0.25 (0.05 to 1.12; p=0.069) 0.24 (0.05 to 1.13; p=0.072) Any referrals 10/1302 (0.77%) 10/1375 (0.73%) 0.95 (0.39 to 2.26; p=0.903) 0.98 (0.37 to 2.59; p=0.965)
*Multivariate model controls for gender, age, highest educational qualification, smoking status, whether there are children aged under 16 years living in the household, any comorbid condition, index of multiple deprivation score and the number of times the patient reported consulting a doctor about an respiratory tract infection in the 12 months prior to the study.
†Reported as the mean (SD) The median is 0 and the IQR is (0, 0) The range is 0–8.
Table 7 Health service use in the 12 months following the date of consent based on review of primary care notes
Univariate risk ratio (95% CI; p=value)
Multivariate risk ratio (95% CI; p=value) Any reconsultations 242/1418 (17.07%) 249/1483 (16.79%) 0.98 (0.83 to 1.15; p=0.843) 0.85 (0.65 to 1.12; p=0.259) Number of
reconsultations † 0.30 (0.88) 0.28 (0.77) 0.92 (0.75 to 1.14; p=0.456) 0.97 (0.79 to 1.21; p=0.806) Any antibiotic
prescriptions
156/1332 (11.71%) 155/1389 (11.16%) 0.95 (0.77 to 1.17; p=0.651) 0.97 (0.76 to 1.23; p=0.811) Any hospitalisations 11/1189 (0.92%) 4/1239 (0.32%) 0.35 (0.11 to 1.09; p=0.071) 0.35 (0.11 to 1.10; p=0.073) Any referrals 16/1192 (1.34%) 15/1249 (1.20%) 0.89 (0.44 to 1.80; p=0.755) 1.11 (0.48 to 2.52; p=0.808)
*Multivariate model controls for gender, age, highest educational qualification, smoking status, whether there are children under 16 living in the household, any comorbid condition, index of multiple deprivation score, and the number of times the patient reported consulting a doctor about a respiratory tract infection in the 12 months prior to the study.
†Reported as the mean (SD) The median is 0 and the IQR is (0, 0) The range is 0–8.
Trang 8symptom duration and the duration of more severe
symptoms was increased—the latter significantly This
could be either a chance finding or possibly that we
made participants more aware of symptoms However,
another possibility is that by strongly encouraging the
use of not only paracetamol but also ibuprofen, the
intervention may have significantly increased ibuprofen
use, and recent trial evidence suggests that advising the
use of ibuprofen is unlikely to help overall symptoms,
and is associated with the progression of symptoms (ie,
prolonging illness)8—presumably due to inhibiting the
inflammatory element of an effective immune response
When the analysis in the current study controlled for
the use of pages that advocated ibuprofen, the finding
of increased symptom duration in the intervention
group was markedly attenuated A possible explanation
for this attenuation could be that use of ibuprofen pages
is a marker of an individual having more severe orflorid
symptoms, and hence, the symptoms might last longer
(ie, reverse causality: the use of ibuprofen pages was
because of severe illness, not causing it) However, this
explanation is rather unlikely as more florid upper
respiratory symptoms and signs are associated with
shorter illness duration,23 and reverse causality cannot
explain why more severe prolonged symptoms were
reported in the intervention group since the number of
infections reported were almost identical in both
groups Thus, the most reasonable inference is that
advice on the use of ibuprofen was probably harmful,
and revised versions of the website should therefore not
encourage ibuprofen use Whatever the reasons for the
finding of more severe symptoms, the presence of more
severe symptoms would be expected to lead to increased
consultations, which makes the reduction in the need for GP contacts more striking—supporting the earlier findings in the development of the intervention, that the website increases enablement and confidence in managing symptoms.12 15
Conclusion
An internet-delivered intervention for managing RTIs helps participants appropriately manage their symptoms and contacts with NHS staff, and may help reduce hospital admissions, but advice to use ibuprofen may be unhelpful
Contributors All authors contributed significantly to the development of the protocol All authors contributed to overseeing the management of the study, agreeing the analysis plan, and to the write-up of the paper PL had the initial idea, led the grant application, and the initial drafting of the paper, and is guarantor LY led the development of the intervention with PA and LM PL,
MM and BS performed the analysis TT and SB performed day-to-day management of the study supervised by PL All authors had full access to all the data (including statistical reports and tables) in the study and can take responsibility for the integrity and the accuracy of the data analysis Samantha Hall, PPI representative, kindly commented on the protocol and outcomes, and contributed to steering meetings.
Funding This study was funded by the National Institute for Health Research Programme Grants for Applied Research programme This article presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research programme (grant ref No RP-PG-0407-10098) The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health Competing interests None declared.
Ethics approval South West MREC.
Provenance and peer review Not commissioned; externally peer reviewed Data sharing statement No additional data are available.
Table 8 Characteristics of participants followed up and not followed up
Did not complete 20-week follow up questions
Did complete 20-week follow up questions
Household composition
Highest qualifications
IMD, index of multiple deprivation; RTI, respiratory tract infection.
Trang 9Open Access This is an Open Access article distributed in accordance with
the terms of the Creative Commons Attribution (CC BY 4.0) license, which
permits others to distribute, remix, adapt and build upon this work, for
commercial use, provided the original work is properly cited See: http://
creativecommons.org/licenses/by/4.0/
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